Comparison of the Effects of Oral Ulceration Healing in Patients Wearing a Removable Denture
NCT ID: NCT06531720
Last Updated: 2024-08-01
Study Results
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Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2023-01-01
2023-12-31
Brief Summary
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Detailed Description
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Patients were asked to use topical medication 3 times a day, applying the size of a pea on the oral mucosa lesion. Participants in groups CHX and CHS were instructed not to eat or drink for 1 hour following the application of medication because of its functional and antibacterial properties. Patients were asked to wear new dentures between control visits, even when they felt discomfort while using them. Patients in the control group were not using any topical medication. According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups.
Using a transparent millimeter grid superimposed on the OML, the Wound Surface Area (WSA) was measured in mm\^2. A very precise measurement of the WSA was possible thanks to the use of a millimeter scale on the digital photo image. Every, even partially filled square was included in the area of the OML. Graphical analysis using Photo for Windows Software consisted of adding all the squares within which the OML was observed. All the intraoral images of OML have been taken in reproducible conditions (ambient light, lens and camera settings, distance 5 cm). This measurements were carried out during all check-up visits on day 0, 1, 4, 7 and 14.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group I: oral mucosa lesions treated with 0,2% CHX topical use,
* Group II: oral mucosa lesions treated with 8,7% CHS topical use and
* Group III: oral mucosa lesions as control group-CON with no specific OML treatment.
The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa, caused by the use of removable prosthetic restorations was analyzed. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. Patients in the control group were not using any topical medication.
TREATMENT
TRIPLE
Study Groups
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0,2% CHX topical use
Patients were asked to use topical medication containing 0,2% chlorhexidine 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days.
Chlorhexidine Gluconate
topical preparation applied on oral mucosa lesion containing 0,2% CHX
8,7% CHS topical use
Patients were asked to use topical medication containing 8,7% choline salicylate 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days.
Choline Salicylate 8.7 % Oral Gel
topical preparation applied on oral mucosa lesion containing, ethanol-based
Control
Patients were not using any topical medications.
control group
no medication has been prescribed
Interventions
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Chlorhexidine Gluconate
topical preparation applied on oral mucosa lesion containing 0,2% CHX
Choline Salicylate 8.7 % Oral Gel
topical preparation applied on oral mucosa lesion containing, ethanol-based
control group
no medication has been prescribed
Eligibility Criteria
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Inclusion Criteria
* partial dentures II and III
* prostheses delivered for the during the period of the study patient
* patient consent
Exclusion Criteria
* prosthetic stomatitis according to Newton's classification
* parafunctional habits, bruxism
* autoimmune diseases
18 Years
ALL
Yes
Sponsors
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Medical University of Silesia
OTHER
Responsible Party
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Locations
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Department of TMD Silesian Medical University
Zabrze, , Poland
Countries
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Other Identifiers
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SUM MUCOSA HEALING
Identifier Type: -
Identifier Source: org_study_id
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